EP1626656A4 - Verfahren zur probenkontrolle und kalibrationsanpassung zur verwendung mit einem nichtinvasiven analysator - Google Patents

Verfahren zur probenkontrolle und kalibrationsanpassung zur verwendung mit einem nichtinvasiven analysator

Info

Publication number
EP1626656A4
EP1626656A4 EP04752964A EP04752964A EP1626656A4 EP 1626656 A4 EP1626656 A4 EP 1626656A4 EP 04752964 A EP04752964 A EP 04752964A EP 04752964 A EP04752964 A EP 04752964A EP 1626656 A4 EP1626656 A4 EP 1626656A4
Authority
EP
European Patent Office
Prior art keywords
spectrum
noninvasive
model
guide
tissue
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04752964A
Other languages
English (en)
French (fr)
Other versions
EP1626656A2 (de
Inventor
Timothy L Ruchti
Kevin H Hazen
Thomas B Blank
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sensys Medical Inc
Original Assignee
Sensys Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US08/911,588 external-priority patent/US6115673A/en
Priority claimed from US09/563,782 external-priority patent/US6415167B1/en
Priority claimed from US09/630,201 external-priority patent/US6871169B1/en
Priority claimed from US10/170,921 external-priority patent/US7206623B2/en
Priority claimed from US10/384,023 external-priority patent/US7010336B2/en
Application filed by Sensys Medical Inc filed Critical Sensys Medical Inc
Publication of EP1626656A2 publication Critical patent/EP1626656A2/de
Publication of EP1626656A4 publication Critical patent/EP1626656A4/de
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
    • G01N21/274—Calibration, base line adjustment, drift correction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/359—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light

Definitions

  • the invention relates to noninvasive determination of analytes in the human body.
  • the invention relates to methods of anaiyte calibration
  • a spectroscopy based noninvasive analyzer delivers external energy in the form of
  • noninvasive system includes the determination of a chemical constituent
  • noninvasive analyzers are magnetic resonance imaging (MRI), X-rays,
  • Diabetes is a chronic disease that results in improper production and utilization of
  • insulin a hormone that facilitates glucose uptake into cells. While a precise cause of
  • diabetes is unknown, genetic factors, environmental factors, and obesity appear to
  • Diabetics often have one or more of the
  • ketoacidosis skin conditions, gum disease, impotence, and fetal complications.
  • Diabetes is a leading cause of death and disability worldwide. Moreover, diabetes is merely one among a group of disorders of glucose metabolism that also include
  • diabetes mellitus a randomized prospective 6-year study, Diabetes Res Clin Pract,
  • a vital element of diabetes management is the self-monitoring of blood glucose
  • glucose concentration is identified as a beneficial development for the management
  • invasive penetrates into the body, the technology is referred to as invasive.
  • infrared [ultraviolet (200 to 400 nm), visible (400 to 700 nm), near-IR (700 to 2500 nm or 14,286 to 4000 cm “1 ), and infrared (2500 to 14,285 nm or 4000 to
  • an apparatus is used to acquire a signal from the body without obtaining a
  • One type of noninvasive glucose concentration analyzer is based upon spectra.
  • a noninvasive apparatus uses some form of spectroscopy to acquire a
  • the signal collected typically includes
  • a region of the body such as a
  • Transflected here refers to collection of
  • transflected light enters the fingertip or forearm in one region and exits in another
  • nm is collected at greater radial or transflected distances from the incident photons.
  • Noninvasive techniques are not limited to using the fingertip as a measurement site.
  • a bioimpedence meter is considered to be a bioimpedence meter
  • a bioimpedence is referred to as a noninvasive glucose analyzer.
  • a bioimpedence is referred to as a bioimpedence
  • meter is a noninvasive device.
  • NIR near-infrared
  • wavelength range 700 to 2500 nm or one or more wavelength ranges therein, such as 1100 to 1800 nm.
  • the light is partially absorbed and partially scattered according
  • light collection means optically coupled to a detector or directly to a detector.
  • detected light contains quantitative information that corresponds to the known
  • a noninvasive glucose concentration analyzer has one or more beam paths from a
  • Light source types include a blackbody source, a tungsten-
  • halogen source one or more LED's, and one or more laser diodes.
  • wavelength spectrometers a wavelength selection device is used or a series of
  • Wavelength selection devices are used for wavelength selection. Wavelength selection devices
  • the source such as varying which LED or diode is firing is also used for wavelength
  • Detectors are in the form of one or more single element detectors or one
  • Detector types include InGaAs, PbS, PbSe,
  • Detector arrays include InGaAs, PbS, PbSe, Si, MCT, or the like.
  • Light collection optics such as fiber optics, lenses, and mirrors are commonly used in various configurations as an output element within a spectrometer to direct
  • Glucose concentration analyzers require calibration. This is true for all types of
  • glucose concentration analyzers such as traditional invasive, alternative invasive,
  • noninvasive, and implantable analyzers One fact associated with noninvasive
  • glucose concentration analyzers is that they are secondary in nature, that is, they do
  • concentration analyzer or any appropriate and accurate traditional invasive reference device such as the THERASENSE FREESTYLE (THERASENSE, INC., Alameda
  • glucose concentration of the molecule of interest (glucose).
  • Chemometric calibration techniques extract glucose related signal from the
  • the models are developed through the
  • concentration vector for each sample spectrum in a calibration include partial least
  • PLS squares
  • PCR principal component regression
  • An apparatus for measuring infrared throughput typically includes an energy source
  • Tissue is irradiated with multiple wavelengths
  • the resulting signal is utilized in a model for determining the anaiyte concentration.
  • Multivariate models reduce a complex measurement in a space modeled with a
  • a calibration is used in combination with noninvasive spectra of a subject to
  • a list of such factors includes at least body
  • Wavelengths include
  • additional reference signal from 1000 to 2700 nm.
  • multivariate model is constructed form plural known biological fluid samples. J. Hall, T. Cadell, Method and device for measuring concentration levels of blood
  • the apparatus uses a receptor shaped to accept a fingertip with
  • concentration determination is to model an individual over a short period of time [see
  • the calibration models are developed from the spectral absorbance of a representative population of patients that have been segregated
  • the groups or classes are defined on the basis of structural and state
  • Classification occurs through extracted features of the tissue
  • model is calibration transfer.
  • nth derivative (n>1), smoothing, Fourier transforming, principle component selection,
  • the model data is modified to reduce
  • the prediction process is modified for each target subject utilizing a minimal
  • reference spectrum contains data collection errors and has spectroscopic attributes
  • period of sampling such as a fraction of a day, one day, or a period of multiple days.
  • pharmacologic or vasodilating agents such as nicotinic acid, methyl nicotinamide,
  • minoxidil nitroglycerin, histamine, menthol, capsaicin, and mixtures thereof to hasten the equilibration of the glucose concentration in the blood vessels with that of the
  • noninvasive glucose determinations as a method of equilibrating glucose
  • Physiological parameters that change the state of skin include: tissue hydration, skin
  • Noninvasive spectra such as a near-IR based diffuse reflectance spectrum
  • the invention herein focuses on maintenance of one or more
  • a guide is used to substantially reduce
  • Figure 1 shows a flat guide coupled to a plug, according to the invention
  • Figure 2 presents an LED attachment coupled to a plug with a 4.5 inch radius of
  • Figure 3 presents a miniaturized source attachment coupled to a 6.0 inch radius of
  • Figure 4 presents a miniaturized source attachment coupled to a flat guide
  • Figure 5 presents spectral variance with and without a guide, according to the
  • Figure 6 presents prediction results overlaid onto a Clarke error grid, according to
  • concentration analyzer to obtain a spectrum of a sample site of an individual in conjunction with a model and a reference anaiyte concentration correction to predict
  • reference spectrum herein refers to a tissue spectrum
  • Equation 1 X meaSured is a vector of a prediction spectrum, W ⁇ is the
  • y nat has
  • the prediction y hat is thought of as an uncorrected
  • glucose concentration is referred to herein as y' hat Often X ref is a mean spectrum, but
  • the analyzer requirements may have loose accuracy requirements such as determining if the anaiyte concentration is high or low. This allows correction of the
  • This offset correction is performed using a direct reference glucose
  • a direct reference glucose concentration is a traditional
  • y bias2 Combining the direct glucose concentration determination step
  • this first method requires collection and use of both a
  • the calibration model results in a glucose prediction, y hat , that has an error associated
  • this error is corrected by using only the direct glucose
  • the direct reference glucose determination here referred to as y ⁇ rr
  • Equations 3 and 4 to represent both of the errors from the more complicated 2-step
  • the reference spectrum is one of a number of spectra, including the first spectrum of
  • time period where the time period includes a day, week, month, or even a
  • correction is performed once a day, waking day, or major fraction of a day.
  • time period is used as may a spectrum that is a linear combination of any number of
  • the reference spectra originates from a data base such as a spectral library and is chosen based
  • a basis set gold standard spectrum such as
  • gold standard spectrum is that it is collected in a controlled environment and is
  • concentration analyzer to obtain a spectrum of a sample site of an individual in
  • Spectrometer light throughput is effected by a number of factors, including
  • tissue state changes that alter the tissue state include
  • Physical changes include localized and/or
  • Noninvasive spectra of the body are dependent upon the sample site. For example,
  • the spectra of a forearm skin tissue sample is different depending upon where on the
  • a skin sample varies as a function of
  • a guide is an element that limits positioning of a sample probe
  • the guide couples an input and output element to a
  • attachments have the same interface so that a single guide element is used with
  • reference sample preferably have the same interface so that they both couple to a
  • sample probe A common interface allows any of the guides or a reference to interface with any of the attachments, such as the plug, photonic stimulator, sample
  • a sample site varies between individuals in terms of circumference or radius of
  • curvature may range from flat to 0.375 inch, respectively. Even within a body part,
  • the radius of curvature varies between individuals. For example, some individuals
  • Examples of guides are those that have flat sample interfaces and those with a 6.0
  • Figure 1 presents a guide element
  • Figure 1 is presented in relation to a plug, which is one of the guide attachments
  • a core feature of the guide element is that is makes up one-half of
  • lock element is in the guide, but alternatively it is in the attachment. In this case, the
  • lock element is a hole in the guide that is roughly rectangular with two opposing
  • the guide would not have rotational freedom. For instance,
  • the pictured guide has C2 symmetry allowing it to be rotated by 180 degrees and still
  • the lock element has pins
  • the magnets are used to control contact force and/or to aid in
  • the guide is attached to a sample site with a device, such as a band, strap, hook
  • the adhesive is attached to the guide and the pair is
  • the adhesive comes to the user already attached to the adhesive.
  • the guide and adhesive are semi-permanently and removeably
  • the guide is typically left in place for the remainder of
  • a sampling period such as one waking day or the length of a data collection period
  • An optional intermediate layer or guide extension is used between the guide and the
  • double sided adhesive that attaches to the sampling site.
  • this is a semi- flexible material such as acetate. The material allows some flexibility to allow the
  • the guide is preferentially formed out of a thermoplastic, such as a polycarbonate or
  • the guide is non-thermally conductive to reduce sampling site temperature
  • thermally conductive guide is preferential
  • the guide material is
  • the guide is optically coupled to the sampling site through the use of
  • an index of refraction matching medium such as a fluoropolymer, a fluorocompound
  • FC-40 Fluorinert, FC-40, FC-70, or equivalent.
  • attachments to the guide element include a
  • a plug attachment is presented in Figure 1 coupled to a guide.
  • the plug functions to
  • the pictured plug has two protruding
  • the plug is
  • the plug looks like a watchband with it.
  • the plug is miniaturized
  • the pictured plug in Figure 1 has an optional central tunnel. This tunnel is used in
  • the adhesive strip has an opening in it that is slightly
  • the guide is attached to the plug and slid down a guiding rod to the adhesive so that the optical path is centered in the cutout on the adhesive.
  • a photonic stimulator attachment is presented in Figure 2 coupled to a guide with a
  • one sample site is used to enhance perfusion of the sample site leading to reduced
  • a sample module is presented in Figure 3 coupled to a guide with a 6.0 inch radius
  • a sample module is preferably part of an analyzer, the analyzer
  • module is attached continuously or semi-continuously to a human subject and
  • the preferred target anaiyte is glucose.
  • the preferred analyzer is glucose.
  • FIG. 4 A miniaturized source attachment is presented in Figure 4 in combination with a
  • a reference element is used to provide a signal
  • the reference element is
  • concentration with smaller variations being related to protein, fat, and temperature.
  • the guide increases the precision of locating the optical probe in relation to
  • instrumentation used to collect the calibration data includes three identically
  • excitation guiding optics a bandpass filter, collection guiding optics, a slit, a grating,
  • a guide is placed onto each subject at
  • the calibration is built with a total of eight
  • routines include modules for detecting and eliminating samples with poor surface
  • the prediction spectra were collected over a five week period
  • prediction data set included spectra collected from twenty-one test subjects on three
  • time period includes a day, week, month, or even a spectrum collected for
  • the correction is performed
  • spectrum is the first spectrum of a time period, the average of the first n spectra of a
  • time period is used, or a spectrum that is a linear combination of any number of time
  • reference spectrum is from a data base, such as a spectral library, and is chosen based upon spectral features or based upon a calculation, such as a Mahalanobis
  • the direct reference anaiyte concentration is typically a
  • concentration is alternatively generated by a minimally invasive glucose meter or a
  • noninvasive meter Generally, an FDA approved reference method is used.
  • a non-linear model such as a neural network

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Optics & Photonics (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Theoretical Computer Science (AREA)
  • Mathematical Physics (AREA)
  • Emergency Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
EP04752964A 1997-08-14 2004-05-20 Verfahren zur probenkontrolle und kalibrationsanpassung zur verwendung mit einem nichtinvasiven analysator Withdrawn EP1626656A4 (de)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US08/911,588 US6115673A (en) 1997-08-14 1997-08-14 Method and apparatus for generating basis sets for use in spectroscopic analysis
US09/563,782 US6415167B1 (en) 2000-05-02 2000-05-02 Fiber optic probe placement guide
US61078900A 2000-07-06 2000-07-06
US09/630,201 US6871169B1 (en) 1997-08-14 2000-08-01 Combinative multivariate calibration that enhances prediction ability through removal of over-modeled regions
US10/170,921 US7206623B2 (en) 2000-05-02 2002-06-12 Optical sampling interface system for in vivo measurement of tissue
US10/384,023 US7010336B2 (en) 1997-08-14 2003-03-07 Measurement site dependent data preprocessing method for robust calibration and prediction
US47261303P 2003-05-21 2003-05-21
US10/849,422 US7383069B2 (en) 1997-08-14 2004-05-18 Method of sample control and calibration adjustment for use with a noninvasive analyzer
PCT/US2004/016064 WO2004104644A2 (en) 1997-08-14 2004-05-20 Method of sample control and calibration adjustment for use with a noninvasive analyzer

Publications (2)

Publication Number Publication Date
EP1626656A2 EP1626656A2 (de) 2006-02-22
EP1626656A4 true EP1626656A4 (de) 2008-04-30

Family

ID=34069497

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04752964A Withdrawn EP1626656A4 (de) 1997-08-14 2004-05-20 Verfahren zur probenkontrolle und kalibrationsanpassung zur verwendung mit einem nichtinvasiven analysator

Country Status (3)

Country Link
US (2) US7383069B2 (de)
EP (1) EP1626656A4 (de)
WO (1) WO2004104644A2 (de)

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